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Acute Myeloid LeukemiaPhase 1NCT00990054

Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 1 study testing Plerixafor in people with Acute Myeloid Leukemia, run by Genzyme, a Sanofi Company at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to determine if plerixafor can make cells more sensitive to killing by cytarabine and daunorubicin, an anti-cancer drug regimen referred to as "7+3" that is commonly used in treating acute myeloid leukemia (AML). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Plerixafor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
8 sitesUnited States
Study dates
Dec 2009to Mar 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide signed, dated informed consent prior to any protocol-specific procedures.
  • Have a diagnosis of newly diagnosed AML, defined as >20% myeloblasts on the marrow aspirate or peripheral blood differential, with or without extramedullary involvement, with confirmatory immunophenotyping or immunocytochemistry (e.g., myeloperoxidase), documented within 14 days of enrollment.
  • Have Eastern Cooperative Oncology Group (ECOG) performance status (Appendix A) score of 0, 1, or 2.
  • Toxicities from all prior treatments have resolved to baseline or δ Grade 1 prior to first dose of study drugs.
  • Are surgically or biologically sterile or willing to practice acceptable birth control, as follows: Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative serum pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives and abstinence.
  • Males must agree to abstain from sexual activity or agree to utilize a medially-approved contraception method during and for 3 months after the treatment period.
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  • Have adequate renal and hepatic function, as indicated by the following laboratory values: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) δ2.5 - upper limit of normal (ULN); Estimated creatinine clearance (CrCl) of > 50mL/min, as calculated by the Cockcroft-Gault equation (Appendix F); total bilirubin ≤1.5-ULN (except in patients with Gilbert Syndrome, in whom direct bilirubin must be ≤1.5-ULN), International Normalized Ratio (INR) ≤1.5 after discontinuation of anticoagulants.
  • Have adequate cardiac function, as measured by left ventricular ejection fraction (LVEF) ≥40% on echocardiography or multigated acquisition (MUGA) scan or similar radionuclide angiographic scan.
  • Be able to comply with study procedures and follow-up examinations.

Who cannot join

  • Have received previous systemic treatment for leukemia or antecedent hematologic disorder (AHD), other than hydroxyurea or hematopoietic growth factors. Treatment with hydroxyurea within 2 weeks of screening is allowed but must be discontinued at least 24 hours prior to the first dose of study drugs.
  • Have received prior treatment with plerixafor, cytarabine, or any anthracycline.
  • Have a diagnosis of acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 or World Health Organization (WHO) classification of APL with t(15;17)(q(22;q12), or Bcr-Abl positive leukemia.
  • For patients < 50 years of age, have cytogenetics associated with good prognosis [(t(8;21)q(22;22), t(15;17),inv(16)(p13;q22)]. (Testing for these mutations must be performed on blood or Bone Marrow prior to study registration.
  • Have had a hematopoietic stem cell transplant (HSCT).
  • Have an absolute blast count of the following at the time of first dose of chemotherapy, despite cytoreduction with hydroxyurea or leukapheresis:
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  • >50 x 10^9/L for patients not enrolled in a G-CSF-containing cohort
  • >25 x 10^9/L for patients enrolled in a G-CSF-containing cohort
  • Have central nervous system (CNS) leukemia (Only patients with suspected CNS leukemia must undergo lumbar puncture.)
  • Have any of the following within the last 12 months: unstable supraventricular arrhythmia (e.g., hemodynamic instability) or has a pacemaker; Any ventricular arrhythmia, other than occasional premature ventricular contractions; Congestive heart failure (controlled or uncontrolled); Myocardial infarction, ischemia, stable coronary artery disease, or angina; Uncontrolled hypertension; Syncope with either a known cardiovascular or an unknown etiology.
  • Have a pre-existing disorder predisposing the patient to serious or life-threatening infection (e.g., cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder, or cytopenias).
  • Have the need for anticoagulant therapy.
  • Have a significant medical or psychiatric disorder that would interfere with consent, study participation, or follow-up.
  • Have an active acute or chronic systemic fungal, bacterial, viral, or other infection (i.e., exhibiting ongoing signs/symptoms related to the infection [except isolated fever] and without improvement, despite appropriate antibiotics or other treatment).
  • Have severe concurrent diseases (e.g., a history of serious organ dysfunction or disease) that may place the patient at undue risk to undergo induction therapy per protocol, or obscure assessments of drug safety.
  • Have a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent, with the following exceptions:
  • Patients with treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or
  • Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values after treatment with curative intent.
  • Have known human immunodeficiency virus (HIV) positivity or evidence of active viral hepatitis.
  • Are pregnant or breastfeeding.
  • Are known to have an allergy to any component of the study drug regimen

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Boston, Massachusetts

  • Study site

    Cleveland, Ohio

  • Study site

    Duarte, California

  • Study site

    Houston, Texas

  • Study site

    Rochester, New York

  • Study site

    Seattle, Washington

  • Study site

    St Louis, Missouri

Other trials in United States

About this study

Official title: A Phase I, Dose Escalation Study of Plerixafor in Combination With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia

The purpose of this research study is to determine if plerixafor can make cells more sensitive to killing by cytarabine and daunorubicin, an anti-cancer drug regimen referred to as "7+3" that is commonly used in treating acute myeloid leukemia (AML). In this study, plerixafor is used with treatments cytarabine and daunorubicin and with and without granulocyte-colony stimulating factor (GCSF). Subjects will be monitored to see how well they tolerate the use of these drugs together and how well they work to treat the leukemia.

The purpose of the study is to determine the maximum tolerated dose (MTD) per plerixafor dosing schedule (once daily [QD] or twice daily [BID]), and/or recommended phase 2 dose (RP2D), by assessing safety and tolerability of plerixafor (Mozobil®) when used in combination with cytarabine and daunorubicin, and with and without granulocyte-colony stimulating factor (G-CSF)

Being tested
Plerixafor
Keywords
Cytarabine,, Daunorubicin,, De Novo,, Acute Myeloid Leukemia,, AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlerixaforDrug

    Also called AMD3100, Mozobil

    240 mcg/kg/dose and proceeding to escalating dose levels for determination of the single-dose maximum tolerated dose (MTD) provided that there are no unacceptable dose limiting toxicities

Study groups in NCT00990054
Study groupRoleWhat they receive
plerixaforExperimentalNot described
Receives: Drug: Plerixafor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the maximum tolerated dose of plerixafor when used in combination with cytarabine and daunorubicin and with and without GCSF

    Measured: 28 days from first dose and up to 42 days following last dose

Secondary outcomes (9)

  1. Anti-leukemia activity of plerixafor when used with cytarabine and daunorubicin

    Measured: Beginning at Day 14 and then until complete remission (CR), complete remission with incomplete count recovery (CRi), or treatment failure (TF)

  2. Maximal plasma concentration (Cmax) of plerixafor when used with cytarabine and daunorubicin

    Measured: Cycle 1 (1 week)

  3. Time to maximal plasma concentration (Tmax) of Plerixafor when used with cytarabine and daunorubicin

    Measured: Cycle 1 (1 week)

  4. Area under the concentration-time curve from time zero to the last observed concentration (AUC 0-last) of plerixafor when used with cytarabine and daunorubicin

    Measured: Cycle 1 (1 week)

  5. Area under the concentration-time curve over the dosing interval (τ) (AUC 0-τ) of plerixafor when used with cytarabine and daunorubicin

    Measured: Cycle 1 (1 week)

  6. Area under the concentration-time curve from time zero to infinity (AUC 0-∞ ) of plerixafor when used with cytarabine and daunorubicin

    Measured: Cycle 1 (1 week)

  7. Half-life (T½) of plerixafor when used with cytarabine and daunorubicin

    Measured: Cycle 1 (1 week)

  8. Volume of distribution (Vz/F for SC administration; Vz for IV administration); in the case of multiexponential disposition, volume of distribution at steady-state (Vss) will be calculated of plerixafor when used with cytarabine and daunorubicin

    Measured: Cycle 1 (1 week)

  9. Obtain preliminary data on safety , tolerability, PK, leukemia cell mobilization and anti-leukemia activity of plerixafor when used in conjunction with G-CSF, cytarabine and daunorubicin.

    Measured: Cycle 1 (1 week) and then until complete remission (CR), complete remission with incomplete count recovery (CRi), or treatment failure (TF)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00990054
Sponsor's protocol ID
MOZ04808
Status last verified
Mar 2015
First submitted
2 Oct 2009
Last updated
24 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Plerixafor in people with Acute Myeloid Leukemia, run by Genzyme, a Sanofi Company at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the maximum tolerated dose of plerixafor when used in combination with cytarabine and daunorubicin and with and without GCSF (time frame: 28 days from first dose and up to 42 days following last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00990054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.

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